Pharmacokinetic Principles in Preclinical Safety Assessment

This webinar will describe the basic principles of pharmacokinetics, with specific emphasis on issues that can impact toxicokinetics in preclinical safety assessment studies. It will highlight methods for the optimization of physicochemical properties in the discovery and development of oral drug candidates and explore some of the preclinical methods used to select first in human (FIH) doses.

Are you and others in your organization aware of the current best practices in understanding and optimizing pharmacokinetic properties? Poor pharmacokinetics often manifests itself during safety assessment studies, where an inability to achieve acceptable exposures can cause significant program delays and/or terminations of otherwise promising new drug candidates. This webinar will highlight the factors responsible for non-linear dose-exposure relationships that can result in expensive failed safety assessment studies. It will also describe some of the approaches used to achieve acceptable exposures through the use of non-traditional formulation and dosing methods

It is essential that preclinical safety assessment data be interpreted in the context of drug exposures. This webinar describes the principles of pharmacokinetics, such as absorption, distribution, metabolism and excretion (ADME), as well as important concepts such as clearance, the volume of distribution and half-life. It also explores methods used to mitigate issues associated with inferior pharmacokinetic and toxicokinetic profiles, such as poor physicochemical properties--primarily solubility and permeability. Finally, it will highlight some of the in vitro and in vivo preclinical methods used to inform human dose projections.

Areas Covered in the Webinar:

Pharmacokinetic principles (ADME):

Absorption

Distribution

Metabolism

Excretion

Understanding clearance, volume of distribution and half life.

What properties must be optimized to improve the pharmacokinetic profile of a new drug candidate.

Bryan H. Norman received his Ph.D. in Organic Chemistry at Emory University and was an NIH Postdoctoral Fellow at Penn State University. After three years at Monsanto/Searle, Bryan joined Eli Lilly and Company in 1993, where he led multiple cross functional drug discovery efforts, many of which culminated in clinical candidates for oncology, endocrine and pain indications. In addition to his expertise in medicinal chemistry, Bryan has significant cross functional drug discovery experience and expertise in additional disciplines, such as biomarkers, pharmacokinetic/pharmacodynamic (PK/PD) relationships, mechanisms of drug metabolism and toxicology. He has specific expertise in the mechanisms and mitigation strategies to avoid drug-induced liver injury (DILI). The breadth of his background has led to his service on many Due Diligence teams to assess potential in-license opportunities. In addition to drug discovery training and consulting activities, Bryan is currently an Adjunct Professor at the Indiana University School of Medicine, where he teaches multiple drug discovery topics. He is a Volume Editor and serves on the Editorial Board of Burger’s Medicinal Chemistry, Drug Discovery and Development. Bryan is currently on the Board of Directors of the Medicinal and Bioorganic Chemistry Foundation and serves on various grant review committees. He has published over 45 papers in peer-reviewed scientific journals, been named an inventor on over 30 U.S. patents and given many invited lectures at scientific conferences and universities. His most recent research interests have focused on the identification of mechanisms associated with drug-induced liver injury and the discovery of novel analgesic agents for use in chronic pain.

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